Received Jan 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
immune thrombocytopenia (ITP) exacerbation; immune thrombocytopenia (ITP) exacerbation; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (immune thrombocytopenia (ITP) exacerbation) and CONDITION AGGRAVATED (immune thrombocytopenia (ITP) exacerbation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: The patient's past medical history included Splenectomy. Previously administered products included for Immune thrombocytopenia: rituximab, fostamatinib, eltrombopag and avatrombopag. Past adverse reactions to the above products included No adverse effect with avatrombopag, eltrombopag, fostamatinib and rituximab. Concurrent medical conditions included Immune thrombocytopenia (difficult-to-control Immune Thrombocytopenia). Concomitant products included Romiplostim for Immune thrombocytopenia. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced IMMUNE THROMBOCYTOPENIA (immune thrombocytopenia (ITP) exacerbation) (seriousness criterion medically significant), CONDITION AGGRAVATED (immune thrombocytopenia (ITP) exacerbation) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with Immunoglobulins nos (Immunoglobulin i.v) (intravenous use) for Immune thrombocytopenia, at an unspecified dose and frequency. At the time of the report, IMMUNE THROMBOCYTOPENIA (immune thrombocytopenia (ITP) exacerbation) and CONDITION AGGRAVATED (immune thrombocytopenia (ITP) exacerbation) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: decreases. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was identified during a retrospective clean-up activity initiated under [withheld] in response to a Health Inspection Observation. This case referred to patient 3 from Supplementary Fig. S1 who had ITP exacerbation. This report describes patients with the initiation or exacerbation of ITP post-SARS CoV-2 vaccination, in particular providing short- and long term outcomes of serial vaccinations in such individuals. This single-center retrospective study included patients more than or equal to 18 years old with pre-existing ITP5 or apparent de novo ITP following SARS CoV-2 vaccination at NYP-WCM from Jan-2021 to May-2022. Patients with ITP were included if they had at least one platelet count following SARS-CoV-2 vaccination (initial series or booster). Ninety-five patients with pre-existing immune thrombocytopenia (ITP) were included with extended observations on 43 previously reported. Sixteen experienced immune thrombocytopenia (ITP) exacerbation following SARS-COV-2 vaccinations. Ten of 84 patients (12%) experienced an immune thrombocytopenia (ITP) exacerbation after dose 1 and 7 out of 10 had another exacerbation and 6 after dose 2 and 1, without counts after dose 2, had an exacerbation following a booster. Three out of 10 received boosters without exacerbation. In summary, six patients with previous exacerbations tolerated subsequent vaccinations, and six patients tolerated previous vaccination(s) but had exacerbation(s) with subsequent doses. Eleven of 16 patients experiencing ITP exacerbation(s) following SARS-CoV-2 vaccine(s) received rescue treatment; 7 with difficult-to-control ITP had been receiving intravenous immunoglobulin (IVIG) every 2 to 8 weeks, with their platelet decreases caused either by SARS-CoV-2 vaccination or the underlying ITP. These seven responded to rescue treatment. The ongoing frequency of IVIG infusions did not change. Of the other 4/11 patients, 2 started a thrombopoietin receptor agonist (TPO-RA) and remain on treatment in complete response (CR)5 9 and 14 months later. The other two received steroid pulses with counts returning to off steroids;1 tapered off TPO-RA over 3 months with normal platelet counts 2 weeks after stopping treatment, and 1 remains on TPO-RA in CR at 12 months This patient was on romiplostim at the time of vaccination and required IVIG every few weeks for rescue, even before immunization. Previous ITP treatments include splenectomy, rituximab, avatrombopag, eltrombopag, and fostamatinib. Although this patient received rescue treatment for "ITP exacerbation" following dose 2 and booster, it was unclear if the severe thrombocytopenia was related to the vaccination or the patient's underlying ITP. The frequency of IVIG administration does not appear to be significantly different during the period preceding time 0 and following vaccination(s). ITP, immune thrombocytopenia; IVIG, intravenous immunoglobulin; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2. Author concluded that continue to recommend SARS-CoV-2 vaccination in those with pre-existing ITP because of the largely benign outcome of vaccination despite the risk of an exacerbation. Several patients proceeded with additional doses despite exacerbations with previous doses and did well; however, others and author also describe patients with recurrent ITP exacerbation. This case was linked to US-MODERNATX, INC.-MOD-2023-710835 (E2B Linked Report).; Reporter's Comments: Company comment: Pre-existing difficult to control ITP is a confounder. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2023-710835:Master case (patient 1 out of 03)
Immune thrombocytopenia (difficult-to-control Immune Thrombocytopenia)
Medical History/Concurrent Conditions: Splenectomy
Romiplostim
Test Name: platelet count; Result Unstructured Data: decreases